Not Cleared Direct

DEN130032 - XPERT MTB/RIF ASSAY

DEN130032 is an FDA 510(k) submission for XPERT MTB/RIF ASSAY, manufactured by Cepheid. The device is a Class 2 Microbiology device with product code PEU cleared through the Direct 510(k) pathway after a 44-day FDA review.

DEN130032 · Cepheid · Microbiology device
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Jul 2013
Decision
44d
Days
Class 2
Risk

DEN130032 is an FDA 510(k) submission (not cleared) for the XPERT MTB/RIF ASSAY. Classified as System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen (product code PEU), Class II - Special Controls.

Submitted by Cepheid (Sunnyvale, US). The FDA issued a Not Cleared (DENG) decision on July 25, 2013 after a review of 44 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3373 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

FDA 510(k) Submission Details - DEN130032

510(k) Number DEN130032 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received June 11, 2013
Decision Date July 25, 2013
Days to Decision 44 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 102d · This submission: 44d
Pathway characteristics

PEU Device Classification - Class 2, Special Controls

Product Code PEU System, Nucleic Acid-based, Mycobacterium Tuberculosis Complex, Resistance Marker, Direct Specimen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3373
Definition The [test] Is Intended For Use With Specimens From Patients For Whom There Is Clinical Suspicion Of Tuberculosis (tb) And Who Have Received No Antituberculosis Therapy, Or Less Than 3 Days Of Therapy. This [test] Is Intended As An Aid In The Diagnosis Of Pulmonary Tuberculosis When Used In Conjunction With Clinical And Other Laboratory Findings.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

DEN130032 · XPERT MTB/RIF ASSAY
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